Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT04109261
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2019-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe
Sponsor:
Fernando Moreno Antón
Organization:
Study Overview
Official Title:
Retrospective Observational Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programme
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALBOCOMP
Brief Summary:
In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data in the clinical practice setting is of clinical interest.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: